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ERX1000 for Obesity

Phase 1
Waitlist Available
Led By Irene Mirkin, MD
Research Sponsored by ERX Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening (day -28 to day -3), check-in (day -2), days 1, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 19, 22, 25, 28, 30 and 37
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and well tolerated in obese subjects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening (day -28 to day -3), check-in (day -2), days 1, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 19, 22, 25, 28, 30 and 37
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening (day -28 to day -3), check-in (day -2), days 1, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 19, 22, 25, 28, 30 and 37 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A (Single Dose Group A9): Incidence and severity of adverse events (AEs)
Part A (Single Dose Group A9): Incidence of 12-lead electrocardiogram (ECG) abnormalities
Part A (Single Dose Group A9): Incidence of clinical laboratory abnormalities
+10 more
Secondary outcome measures
Plasma Exchange
Part A (Single Dose Group A9): Plasma PK outcome endpoint of ERX1000, AUC0-∞
Part A (Single Dose Group A9): Plasma PK outcome endpoint of ERX1000, Cmax
+61 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ERX1000Experimental Treatment1 Intervention
ERX1000 powder provided for preparation of a 4 mg/10 mL oral suspension and 8 mg/10 mL oral suspension Proposed dose level for Part A: 4 mg and 8 mg Proposed dose level for Part B: 4 and 8 mg. The dose administered will not exceed the highest dose administered in Part A.
Group II: PlaceboPlacebo Group1 Intervention
Reference product: Magnesium hydroxide carbonate powder prepared in an oral suspension
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ERX1000
2019
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

ERX PharmaceuticalsLead Sponsor
Irene Mirkin, MDPrincipal InvestigatorLabcorp Clinical Research Unit Inc.
6 Previous Clinical Trials
95 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Wisconsin
Illinois
How old are they?
18 - 65
What site did they apply to?
Covance Clinical Research Unit Inc.
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
ERX1000 - Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Male and Female Subjects With Obesity
2019. "ERX1000 - Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Male and Female Subjects With Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04890873.
~9 spots leftby Apr 2025
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